Joline GmbH & Co. KG
DE-MF-000005494 · Germany · Hechingen
Joline GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|---|
| Class I | 2 |
Among these devices, 8 are declared sterile.
Devices declared under this manufacturer
- QuattroMix
Catalogue references include KMC, KNIPSA1100, KNIPSA500, MC, RU9610, RU9620.
European nomenclature codes declared: P099002, C01901102, F900299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | JOLINE GMBH & CO. KG (DE) · FDA 3004734264 |
| Devices in EUDAMED | 8 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | JOLINE GMBH & CO. KG |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| First licensed | 2026-02-18 |
Licence types: Single Device (2), System (2), Device Group Family (1), Device Family (1).
Licensed under: KYPHOPLASTY SYSTEMS ALLEVO, ALLEVO KYPHOPLASTY CURETTE, JOLINE ALLEVO KYPHOPLASTY BALLOON CATHETER FAM, JOLINE KYPHOPLASTY SYSTEMS ALLEVO STOP'N GO DO, VACUUM SYRINGE, JOLINE KYPHOPLASTY SYSTEM ALLEVO.
North American profile: Both markets. Joline GmbH & Co. KG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
50565-61-A3-00 | reissued | 2030-11-29 |
50565-61-A2 | amended | 2025-11-29 |